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Shire to Conduct Trials on Vyvanse on FDA's Request

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Shire plc (SHPG - Free Report) announced that it has agreed to conduct pediatric clinical studies following FDA’s request to investigate the potential use of Vyvanse for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged between 4 and 5 years.

Vyvanse is already approved in the U.S. for the treatment of ADHD in patients aged 6 years and above.

Shire is currently developing design protocols for three clinical trials on Vyvanse among preschool children. The three trials include a pharmacokinetic study to help determine appropriate dosing and evaluate safety and tolerability, an efficacy and safety study and an open-label study to evaluate long-term safety.

Meanwhile, a Data Monitoring Committee will be set up to monitor patient safety throughout the duration of the clinical program. Shire expects to initiate the first trial in this clinical program in the first half of 2015.

The comapny will enjoy the benefits of the Best Pharmaceuticals for Children Act once the FDA confirms a timely submission and review of data that fulfils the requirements of its request for the trial. The benefits include a six-month extension for Vyvanse patents, which expire in 2023.

We note that Shire holds a strong position in the ADHD market driven by key drugs like Vyvanse, Intuniv and Adderall XR. The growth engine of Shire is Vyvanse. We are also encouraged by Shire’s efforts for the label expansion of Vyvanse. Shire is currently evaluating Vyvanse for additional indications such as the binge eating disorder and expects to submit a Supplemental New Drug Application (sNDA) to the FDA by the third quarter of 2014.

Shire currently carries a Zacks Rank #2 (Buy). Some other stocks that look attractive in the healthcare sector include Allergan (AGN - Free Report) , Gilead Sciences (GILD - Free Report) and Alexion Pharmaceuticals (ALXN - Free Report) .

While Allergan and Gilead Sciences carry a Zacks Rank #1 (Strong Buy), Alexion Pharma is a Rank #2 (Buy) stock.

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